NCT01760343

Brief Summary

A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

December 24, 2012

Last Update Submit

April 4, 2013

Conditions

Hereditary Angioedema Types I and II

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events (AEs) within 24 hours of CSL830 infusion

    From the start of infusion to 24 hours after the end of infusion

Secondary Outcomes (3)

  • Incidence of adverse events (AEs) within 10 days of the CSL830 infusion

    From the start of infusion to 10 days after the infusion

  • Relative bioavailability of CSL830 versus Berinert - Cmax

    240 hours

  • Relative bioavailability of CSL830 versus Berinert - AUC

    240 hours

Study Arms (2)

Berinert, then CSL830

EXPERIMENTAL

A single intravenous dose of Berinert at 1500 units (1500 IU), followed by a single intravenous dose of CSL830 at 1500 IU.

Biological: BerinertBiological: CSL830

CSL830, then Berinert

EXPERIMENTAL

A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU.

Biological: BerinertBiological: CSL830

Interventions

BerinertBIOLOGICAL

Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution.

Berinert, then CSL830CSL830, then Berinert
CSL830BIOLOGICAL

CSL830 is a formulation of Berinert.

Berinert, then CSL830CSL830, then Berinert

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects without clinically significant medical conditions or laboratory abnormalities
  • Male or female subjects aged 18 to 45 years inclusive, at the time of informed consent
  • Non-smokers
  • Body mass index of 18.0 to 29.0 kg/m2 inclusive

You may not qualify if:

  • Previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit.
  • Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
  • Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit.
  • Alcohol, drug, or medication abuse within one year before the study.
  • Female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
  • Participation in another clinical study (or use of another IMP) within 30 days (or 5 times the half-life, whichever is longer) before, or during, the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study Site

Berlin, Germany

Location

MeSH Terms

Conditions

Hereditary Angioedema Types I and II

Interventions

Complement C1 Inhibitor Protein

Condition Hierarchy (Ancestors)

Angioedemas, HereditaryAngioedemaVascular DiseasesCardiovascular DiseasesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesComplement C1 Inactivator ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsComplement Inactivator ProteinsComplement System ProteinsImmunoproteinsBlood ProteinsProteins

Study Officials

  • Global Clinical Program Director

    CSL Behring

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2012

First Posted

January 4, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

DE(1)